Tolvaptan is chemically described as (±)-4′-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl)carbonyl]-otolu-m-toluidide. Its empirical formula is C26H25ClN2O3, with structural formula as follows:

In the United States, tolvaptan is available as oral tablets containing 15 mg and 30 mg of tolvaptan, with trade name SAMSCA® by Otsuka America Pharmaceutical for the treatment of clinically significant hypervolemic and euvolemic hyponatremia.
U.S. Pat. No. 5,258,510 disclose tolvaptan.
U.S. Patent Application Publication No. 2010/0323006 A1 discloses process for the preparation of tolvaptan compositions by a method, comprising: 1) producing an amorphous composite from tolvaptan and hydroxypropyl cellulose; 2) mixing the amorphous composite obtained in step 1 with at least one member selected from the group consisting of low substituted hydroxypropylcellulose, carmellose, sodium carboxy methyl starch, and crospovidone; and 3) processing the mixture obtained in step 2 into a solid preparation.
Still, there is a need to develop alternative compositions of tolvaptan using simplified process. Accordingly, inventors of the present invention developed novel compositions of tolvaptan and process for preparing the same.